Early Feasibility Study Approved for Medtronic's Intrepid TMVR System Using Transfemoral Access

September 27, 2019—Medtronic announced FDA approval to start an early feasibility study for the company’s Intrepid transcatheter mitral valve replacement (TMVR) system using a minimally invasive transfemoral access approach.

According to Medtronic, the prospective, multicenter, nonrandomized early feasibility study will evaluate the safety and performance of the Intrepid TMVR system with the transfemoral approach in patients with severe, symptomatic mitral regurgitation who are ineligible for conventional mitral valve surgery. The study will enroll and treat up to 15 patients who require mitral valve intervention at up to six centers. Patients will be followed up with at 1, 3, 6, and 12 months, and every 6 months thereafter through 5 years.

“We are optimistic about the potential benefits of the transfemoral approach for mitral valve replacement—which is less invasive than the transapical technologies currently in pivotal trials,” said national coprincipal investigator Martin B. Leon, MD, in the company’s announcement. Dr. Leon is Director of the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Medical Center, and Professor of Medicine at the Columbia University College of Physicians and Surgeons, in New York City, New York.

Medtronic noted that this announcement builds upon primary endpoint outcomes of the APOLLO clinical trial, which evaluated the Intrepid TMVR system using the transapical approach, published by Bapat et al in Journal of the American College of Cardiology (2018;71:12–21).

“The early clinical results we have seen with Intrepid and this early feasibility study advances the TMVR field as we look for less invasive ways to treat this patient population, of which a large proportion are considered too high risk for surgery,” said Dr. Leon.

In the company’s announcement, the Intrepid TMVR system is described as integrating a self-expanding, dual-stent technology with a tissue valve that is delivered through a catheter and placed directly into the native mitral valve to restore normal blood flow through the heart without the need for open-heart surgery.

The Intrepid TMVR system is available for investigational use only and it is not approved anywhere for use outside of clinical studies, advised Medtronic.